Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient K
FDA device recall Z-0579-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- ArthroCare Medical Corporation
- Reason for recall
- Potential breach of sterile barrier due to defective product tray.
- Action taken
- The firm notified their consignees on 10/29/14 via letter with a response form included. The letter requested the consignees discontinue use of the device and return it to the vendor.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 23,119 devices
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Sp
- Date initiated
- 2014-10-27
- Date posted
- 2014-12-16
- Date terminated
- 2015-10-09
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ARTHROCARE ARTHROWANDS (K083306) | Arthrocare Corp. | 2008-12-10 |